The Food and Drug Administration (FDA Philippines) published news regarding guidelines about relying on the decisions of other regulatory agencies to facilitate the evaluation of clinical trial applications.
The FDA pitched the new guidance to improve access to investigational drug products for public health emergencies, rare diseases, and ‘emerging and re-emerging infectious diseases of public health threats’. The document sets out the rules for sponsors, contract research organizations, investigators, and research ethics committees that are involved in all phases of multi-region clinical trials.
Under the guidance, drug developers can receive clearance to run some clinical trials under the abridged regulatory pathway. The pathway enables FDA to solely or partially base its decision on the…
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